labelling and packaging

DISPENSING & MEDICATION COUNSELING

LABELING & PACKAGING

LABELING & PACKAGING

Why is proper LABELING & PACKAGING important in Dispensing?

Importance of Packaging and Labeling in Pharmaceutical IndustryThe products manufactured to resolve

health issues would be of no use if they are not packed and labeled appropriately.

It is vital for any pharma product that it remains in its original form and maintains its quality until it reaches the hands of end users. Packaging and labeling are two individual activities that have to be performed as per their significance.

LABELING

• The U.S. Federal Food, Drug and Cosmetic Act (FFDCA) defines "labeling" as all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article. The term 'accompanying' is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instructions, websites, etc.

LABELING Drug labeling refers to all of the printed

information that accompanies a drug, including the label, the wrapping and the package insert.

one of the crucial factors that determines the safety and integrity of the product. This operation includes both printing on the carton and leaflets provided individually with the pharma products.

The primary purpose of labeling is to make identification of the product clear and unambiguous. It conveys essential information to the patient on the use of the preparation.

Guidelines for Labeling Pharmaceutical and Healthcare Products

- An important part of what the FDA does is regulating labeling standards for pharmaceutical, medical, nutraceutical and dietary products.

Properly Labeling Pharmaceutical Product1. Labeling Responsibilities

• According to the FDA, all labels printed for use in the pharmaceutical and healthcare industry are required to be designed and applied so they can remain in place and be read in different environments through distribution, storage and use.

• The label print must be legible and will remain that way throughout the product’s life span. Product manufacturers are responsible for complying with content and format requirements.

2. Displaying Product Information

• All types of labeling have content requirements for what types of information and claims can be stated on a label.

• Checklist of important things to include on a pharmaceutical or healthcare product label:

Official product nameActive and inactive ingredientsDrug Facts tablePurpose and useWarningsDirectionsAllergic reactions

Properly Labeling Pharmaceutical Product

• Additional labelling 1. Batch number2. “ for animal treatment only” on

verterinary prescriptions.3. Storage conditions4. Precautions relating to use of

productsEx. “ caution: Flammable” keep away

from flame.“Not to be consumed by mouth”


• Other examples:DO not swallowTake X times a dayPut two drops in the affected eye.For creams and ointments: spread

thinlyFor pessaries/ suppositories:

Gently put on into the vagina/ rectum


3. Formatting Labels for FDA Approval

• Labels must be designed in the appropriate FDA format for a product’s classification like OTC medications, oral contraceptives, combination products, etc.

• Some things to be considered when designing labels for FDA approval:

Font size and type (must be legible)Language (appropriate use of abbreviations,

grammar, advertised claims, etc.)Format (organization and appearance of

sections like Drug Facts, warnings, uses, etc.)Materials (depending on the nature of the

product)


Properly Labeling Pharmaceutical Product4. Choosing Approved Materials

• Label materials for pharmaceuticals aren’t as stringently regulated as the packaging/container that will touch the drug product. Label materials can be made from standard white paper stock to holographic films to shrink sleeve labels.

• Multi-layer labels (also known as booklet labels) are often used because pharmaceutical and healthcare products are required to share large amounts of information. For further product safety, adhesives, coatings and inks must be “low migration” meaning that little to no substances transfer from the materials to the drug or device.


5. Controlling Label Quality

• Every label printed should be inspected thoroughly to ensure the information is consistent and accurate. Industry standards must be met for safety and liability reasons.


Printing multiple pharmaceutical labels:

• The products should be separated to prevent any mix-ups or switches.

• Product separation can be physical or spatial, or can be completed by performing press runs at different times to avoid confusion.


Proper control of storage:

• An important consideration, proper storage control is necessary for preventing any mix-ups or switches when dealing with labels printed for use in the pharmaceutical industry.

• Labels should be carefully examined to ensure they comply with FDA standards and specifications.

How should you label a patient's prescribed medication ?

The label on the patient's medicine should contain the instructions that the doctor wrote out on the prescription.

The information on the medicine's dispensing label usually includes:

• patient's name • doctor's name• the name and address of the pharmacy that

dispensed the medicine • the date the medicine is dispensed • the generic & the brand name of the medicine • the dose the patient should take, how to take it and

how often • the amount of medicine in the container and the

dosage strength • if necessary, any cautions or warning messages that

apply to the medicine

Prescription Label Sample

Detailed Requirements for Labeling a Patient's prescribed medication

1.All labels must have a patient's info such as:• (Mr., Mrs., Ms.) not to confuse with the

other family members.• Name & Address of the pharmacy & the

date when it was dispensed

2. Must state the Name, Strength, & the Quantity of the medication dispensed.

3. Products for internal use should have White Label and Red Label for external use.

4. It is required to indicate the Month and Year after which the product should not be used such as:

discard after 03-01-16


5. Warning Labels such as:

• Suppository - "For rectal use only, don't swallow."

• Gargles & Mouthwash - "Not to be swallowed."

• Pessaries - "For vaginal use only, don't swallow."


6. Use of Active Verbs such as:

• Take two - NOT - "Two to be taken"

• Use one - NOT - "One to be used"

• Insert one - NOT - "One to be inserted"


7. Frequency and Quantity of formulations should be expressed in Words rather than in Numerals.

× Take 1 cap 2 x a day (misinterpreted)

Take one capsule two times a day× Take two three times a day

(misinterpreted)Take two tablets three times a day.


8. Dosage instruction should be appropriate.

× Never use "Take" if it is NOT for oral route

Use "Apply"

9. Be prepared to give VERBAL explanation on the label.


Proper Positioning of Label

• Medicine Bottles– Label should be on the front of a

medicine bottle about third of the way down the container.

• Cartons– Label should be on the large side of the

carton.– or placed around the carton.

• Ointment Jars/ Tubes– Label should be placed on the side of the

jar or tube.

PACKAGING

Are containers that preserve the quality of a medicine for the stated shelf life.

This containers must maintain the safety, stability of the medicine & protect the product against physical, climatic, chemical & biological hazards.

• In the pharmaceutical industry it is vital that package selected adequately preserve the integrity of the product.

• The selection of a package therefore begins with the determination of the product's physical & chemical characteristics, its protective needs and marketing requirements.

PACKAGING

Materials for packaging SHOULD:

－ protect the product from physical damage－ protect the product from chemical &

microbial contamination－ protect the product from light & moisture － protect the product from environmental

condition－ be FDA approved

PACKAGING

Materials selected should NOT:

－ allow product leakage－ chemically react with the product－ release components－ uptake product components－ be toxic－ impart odor or taste to the product

PACKAGING

Types of Packaging

1.Primary packaging

- is the term used to designate the layer of packaging in immediate contact with the product; in other words, it is the first packaging layer in which the product is contained. As such, primary packaging is constructed both with the product itself and any existing secondary layers of packaging in mind.

PACKAGING

• PRIMARY PACKAGING

PACKAGING

Types of Packaging

2. Secondary packaging

- is not in direct contact with the actual product, its use and application usually differ distinctly from those of primary packaging.

• Secondary packaging is intended to protect not only the product, but also the primary packaging, which often is the packaging most visible to the consumer in retail displays.

• The most common examples of secondary packaging include cardboard cartons, cardboard boxes and cardboard/plastic crates.

PACKAGING

• SECONDARY PACKAGING

PACKAGING

1. GLASS

Type 1 Type 2 Type 3

Different Types of Packaging Materials

Advantages of Glass

• commonly used in pharmaceutical industry because it possesses superior protective qualities, economical and containers are readily available in variety of sizes & shapes.

• inert to most medicinal products

• impervious to air & moisture

• can be colored to protect contents from harmful wavelengths of light

• easy to clean & sterilize by heat

1. GLASS

Type 1 Type 2 Type 3


Disadvantages of Glass

• it is fragile

• release alkali into the container's content

• expensive than plastic

• heavy

• increased transport cost due to fragility & heaviness

1. GLASS

Type 1


TYPE 1 GLASS

• other name is Neutral or Borosilicate Glass

• suitable packing for to almost all pharmaceutical preparations

• but expensive

• used to package sol'n that could dissolve basic oxides in the glass

• increase the pH of the formulation & could affect the drug stability & potency

1. GLASS

Type 2


TYPE 2 GLASS

• other name is de-alkalized Soda-Lime-Silica Glass

• high hydrolytic resistance due to the surface treatment of the glass

• used to package aqueous preparation

• not suitable for parenteral formulations with a pH less than 7

• lower melting point

• easier to produce & consequently cheaper

1. GLASS

Type 3


TYPE 3 GLASS

• other name is untreated Soda-Lime-Silica Glass

• contains more leachable oxides than Type 2 glass• suitable for non-aqueous parenteral products and powder for injection

• used to produce dispensary metric medical bottles

TYPES OF GLASS CONTAINER

1. BOTTLE • commonly used in the dispensary as either amber

metric medical bottles or ribbed (fluted) oval bottles

• 50 - 500 ml• screw closure

PACKAGING

• Parts of TYPICAL bottleNeck finishShoulderBodyIn sweep heelHush upBottom plate

PACKAGING

2. Ribbed oval bottle- Used to package liniments, lotions,

inhalations, and antiseptic solutions.

PACKAGING

3. Dropper bottles- Quantity allowed for 10 to 20 mL- Used mostly for ear, eye and nasal

drops- Hexagonally shaped amber glass

flaten on 3 sides- Fitted with a cap, rubber and dropper

as a closure.

PACKAGING

4. JARSUsed to package powders and semi-

solid preparation.Clear or amber glass15 to 500 mL capacityWide mouth cylindrical jarEx. Oinment jar

PACKAGING

• Examples of medications packaged as jars.

PACKAGING

5. Glass ampulesParenteral containersParts:

StemShoulderbody

PACKAGING

6. Glass vials- used to package parenteral preparation that will be used on more than one occasion.

- 500 mL glass• Dust cap

• Aluminum sealing ring

• Rubber plus

PACKAGING

• PLASTICS-containers for products and as secondary

packaging in the form of a carton.-infusion fluids and small volume injections

2 TYPES:1. THERMOSETS- used for making screw

caps for glass and metal containers.

PACKAGING

• Cont. 2. THERMOPLASTIC-wide variety of pharmaceutical

packages.

PACKAGING

THERMOSETSTHERMOPLASTICS

PACKAGING

• Advantages of using plastics:1. Release few particles into the

product.2. Are flexible and not easily broken3. Low density, low in weight4. Can be heat sealed5. Easily molded into various shapes6. Cheap-ER7. Suitable for use as container

PACKAGING

• Disadvantage1. Not as chemically inert as Type I glass2. Plastics undergo stress cracking and

distortion from contact with some chemical

3. Plastics are heat sensitive4. Not as impermeable to gas and vapour

compared to glass5. May possess an electrostatic charge which

will attract particles6. Additives in the plastic are easily leached

into the product.

PACKAGING

• Additives used in plastic containers:1. Plasticizers2. Resins3. Stabilizers4. Lubricants5. Anti-static agents6. Mold release agents

PACKAGING

• PLASTIC MATERIALS used in Pharmaceutical Packaging.

1. Polyethylene2. Polyvinyl Chloride3. Polypropylene4. Polystyrene

PACKAGING

• PLASTIC MATERIALS1. PolyethyleneLDPE - more flexible, softer, easily

stretched (squeeze bottles)

HDPE - stronger, stiffer, less clear, less permeable to gases,

more resistant to oils, chemicals and solvents.

- solid dosage forms

PACKAGING

• DISADVANTGES OF USING HDPE and LDPE

1. Softened by flavoring and aromatic oild2. Unsuitable for packaging oxygen

sensitive products owing to high good permeability.

3. Adsorb antimicrobial/ preservative agents

4. Crack on contact with organic solvents.

PACKAGING

2. POLYVINYL CHLORIDE (PVC)-Rigid packaging materials- Main component of IV bag

PACKAGING

3. POLYPROPYLENE- Strong, stiff plastic poymers with good

resistance to cracking when flexed.- Suitable for use in closures with hinges

which must resist repeated flexing.- Tablet containers- IV bottles- Higher temp capability over

polyethylene.

PACKAGING

4. POLYSTYRENE- hard, clear, brittle material with low

impact resistance- Tubes and amber fitted bottles- Jars for ointments and creams with

lower water content.

PACKAGING

• PAPERUsed more than any other material in

packaging.-Predominant secondary and tertiary

packaging material.Ex. Carton- primary packaging

PACKAGING

• Patient Pack Dispensing- Consists of a course of medication

together with a patient information leaflet in a reast to dispense pack.

- Ex. Liquid Flation-standard packSolid dose- stirp or blister pack.

PACKAGING

labelling and packaging

Health & Medicine

labeling drug

labeling standards

labeling responsibilities

product information

primary purpose of labeling

official product

product manufacturers

product clear